OPTIMIZER® 10-F202-3-US

GUDID 00810003380029

OPTIMIZER Mini Charger System consists of: (1) OPTIMIZER Mini Charger (with attached charging wand) (1) Battery Charger (1) EU Plug Adapter (1) US Plug Adapter (1) Carrying Case

IMPULSE DYNAMICS (USA) INC.

Implant battery charger
Primary Device ID00810003380029
NIH Device Record Key81863a31-61b8-4c35-8ae8-302fc8e5ab8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPTIMIZER®
Version Model NumberMini Charger System
Catalog Number10-F202-3-US
Company DUNS878519342
Company NameIMPULSE DYNAMICS (USA) INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com
Phone845-359-2389
Emailcontact.us@impulse-dynamics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100810003380029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QFVImplantable Pulse Generator

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

On-Brand Devices [OPTIMIZER®]

00810003380029OPTIMIZER Mini Charger System consists of: (1) OPTIMIZER Mini Charger (with attached charging wa
00810003380005OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists o

Trademark Results [OPTIMIZER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIMIZER
OPTIMIZER
98404259 not registered Live/Pending
SKS Industries, Inc.
2024-02-13
OPTIMIZER
OPTIMIZER
90510200 not registered Live/Pending
Enerco Group, Inc.
2021-02-04
OPTIMIZER
OPTIMIZER
90239421 not registered Live/Pending
Optimatics Pty Ltd
2020-10-07
OPTIMIZER
OPTIMIZER
88781257 not registered Live/Pending
Matthew Bulmer
2020-01-31
OPTIMIZER
OPTIMIZER
88352470 not registered Live/Pending
Conmed Corporation
2019-03-22
OPTIMIZER
OPTIMIZER
88048884 not registered Dead/Abandoned
Encapsulation Technologies, Inc.
2018-07-23
OPTIMIZER
OPTIMIZER
87750751 not registered Live/Pending
Global Marine Networks, LLC
2018-01-10
OPTIMIZER
OPTIMIZER
87191841 5204394 Live/Registered
Todd Williams
2016-10-03
OPTIMIZER
OPTIMIZER
87191841 5204394 Live/Registered
Cynthia Williams
2016-10-03
OPTIMIZER
OPTIMIZER
86717298 not registered Dead/Abandoned
FLUIDMASTER, INC.
2015-08-06
OPTIMIZER
OPTIMIZER
86392126 4723557 Live/Registered
SJB BRANDS, LLC
2014-09-11
OPTIMIZER
OPTIMIZER
86019691 4973519 Live/Registered
MINDRAY DS USA, INC.
2013-07-25

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